Themen – Stellungnahme zur Nutzenbewertung von Ivosidenib (Patient*innen mit lokal fortgeschrittenem oder metastasiertem Cholangiokarzinom (CCA)) vom 06. November 2023

• Literatur

• 1 AWMF S3 Leitlinie: Diagnostik und Therapie des hepatozellulären Karzinoms und biliärer Karzi- nome, August 2023. 032-053OLl_S3_Diagnostik-Therapie-Hepatozellulaere-Karzinom-biliaere- Karzinome_2023-08.pdf (awmf.org)
• 2 Sinn M. et al. Biliäre Karzinome. Leitlinien von DGHO, OeGHO, SGMO und SGH+SSH, Status Oktober 2021. https://www.onkopedia.com/de/onkopedia/guidelines/maligne-biliaeretumoren/@@guideline/html/index.html
• 3 Oh DY, He AR, Qin S. et al. Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer. NEJM Evid 2022; 1 (08)
• 4 Lamarca A, Palmer DH, Wasan HS. et al. Second-line FOLFOX chemotherapy versus active symp- tom control for advanced biliary tract cancer (ABC-06): a phase 3, open-label, randomised, con- trolled trial. Lancet Oncol 2021; 22: 609-701
• 5 Abou-Alfa GK, Macarulla T, Javle MM. et al. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2020; 21: 796-807
• 6 Zhu AW, Macarulla T, Javle MM. et al. Final Overall Survival Efficacy Results of Ivosidenib for Pa- tients With Advanced Cholangiocarcinoma With IDH1 Mutation. JAMA Oncol 2021; 7: 1-10
• 7 ESMO-MCBS Scorecards | ESMO
• 8 Morden JP, Lambert PC, Latimer N. et al. Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study. BMC Med Res Methodol 2011; 11: 4